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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Perfusion Syringes Recalled for Failed Biocompatibility Testing

Agency Publication Date: December 5, 2025
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Summary

Medline Industries, LP is recalling 15 units of Medline Perfusion Syringes (REF: DYNJ39223C) containing specific BD Luer Tip Caps. The recall was initiated because the tip caps failed routine biocompatibility testing conducted by the supplier, Becton Dickinson (BD). While the cap covers a small area and does not touch patients directly, materials from the cap could potentially interact with the liquid inside the syringe before use.

Risk

Failure of biocompatibility testing means the materials in the tip cap could potentially cause adverse health effects such as skin sensitization, irritation, fever-inducing reactions, or systemic toxicity. The severity of the risk depends on the nature and duration of the contact between the syringe contents and the defective cap.

What You Should Do

  1. This recall affects Medline Perfusion Syringes (Reference Number DYNJ39223C) identified by lot number 25FMJ081.
  2. Check the product packaging for UDI/DI 10193489621532 (for individual units) or 40193489621533 (for cases) and the lot number 25FMJ081 to determine if your stock is affected.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For additional questions or to report a problem, call the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MEDLINE PERFUSION SYRINGE
Model / REF:
DYNJ39223C
Lot Numbers:
25FMJ081
UDI:
10193489621532
40193489621533

15 units affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97968
Status: Active
Manufacturer: Medline Industries, LP
Manufactured In: United States
Units Affected: 15 units
Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.